Senior PV Officer

SmartRecruiters, Inc.; Pune District; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

PrimeVigilance is a global pharmacovigilance specialist focused on patient safety from development through post-market surveillance. We seek curious problem-solvers who care about accuracy and impact, across a culture of kindness, growth and belonging.

Join our team to advance ICSR management, ensure regulatory compliance, mentor colleagues, and support PV processes for global clients while contributing to a patient-centric safety mission.

Qualifications

• Life science graduate or healthcare qualification with pharmacovigilance exposure.
• 10–12 years of work experience in pharmacovigilance.
• Excellent written and verbal communication skills.
• Strong organization and multitasking abilities.
• Proficiency in MS Office and planning.

Responsibilities

• Provide support to project team activities for clients and the company.
• Process ICSRs from all sources in compliance with regulations and timelines.
• Perform ICSR follow up and SAE/SUSAR management.
• Handle personal data protection and QA interactions.
• MedDRA and WHO coding; prepare monthly client reports.

Skills

Communication skills

Organization skills

Planning & time management

Technical skills

MS Office

Education

Life science / Pharmacy / Nursing degree

Tools

MS Office

Job description

Medicine moves forward here. So will you.

At PrimeVigilance, patient safety is not one part of the job. It is why we exist.

We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on.

That work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from.

If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you.

Job Description

• Providing support to other activities undertaken by the project team on behalf of the client and the company
• Performing activities in the scope of ICSR management unit within agreed extent and imeframe (including, but not limited to):
• Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
• Performing ICSR follow up
• SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
• Personal data protection
• Product Quality Complaint handling and interaction with Quality Assurance
• Medical Information interaction
• MedDRA and WHO coding
• Database Outputs and Reports (including data for monthly reporting to clients)
• Workflow & resource management
• Mentoring and training of new and more junior employees within the department
• Support of PV processes related to the ICSR management within PrimeVigilance and also to clients
• Supporting ICSR SMEs or contributing as one of ICSR SMEs
• More senior colleague may perform tasks assigned as per SOP to more junior position
• Performing activities in the scope of ICSR management unit within agreed extent and Timeframe
• Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

Qualifications

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
• 10-12years of work experience in pharmacovigilance
• Excellent communication (written and verbal) skills
• Organization skills, including attention to details and multitasking
• Planning and time management
• Technical skills
• Advanced literacy (MS Office)

Additional Information

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You'll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

Quality: we hold ourselves to the standard patients deserve.

Integrity and trust: we do the right thing, especially when it is hard.

Drive and passion: we care about the outcome, because someone is waiting on it.

Agility and responsiveness: we move quickly, because patients cannot wait.

Belonging: everyone is welcome, and every voice counts.

Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.